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RECRUITING
NCT05686759
PHASE3

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

Sponsor: GC Biopharma Corp

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

Official title: A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2023-04-13

Completion Date

2026-06-30

Last Updated

2025-06-25

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Undiluted I.V.-Hepabig inj(GC5103)

undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

BIOLOGICAL

Diluted I.V.-Hepabig inj(GC5103)

Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Locations (8)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea